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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls

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 Class 2 Recall
Curlin
see related information
Date Posted August 07, 2007
Recall Number Z-1129-2007
Product Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets.
Code Information Model Numbers 340-4111- Lot # D628223, D627616, D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716
Recalling Firm/
Manufacturer
Curlin Medical Llc
15751 Graham St
Huntington Beach, California 92649-1630
For Additional Information Contact Marc Drobnack
714-893-2200 Ext. 141
Reason for
Recall
The Administration Sets may leak at the reservior bag.
Action A Field Correction Advisory (Recall Letter) was issued on February 9, 2007 to the firm's one US Customer (distributor): B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets 340-4111- Lot # D628223 and D627616 because the affected lots do not meet acceptable performance levels. A second Field Correction Advisory (Recall Letter) was issued on March 15, 2007 to B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets: 340-4111- Lot # D628223, D6276l6 ,D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716 because the affected lots do not meet acceptable performance levels.
Quantity in Commerce 25, 280
Distribution One US Customer (distributor): B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109
 
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